PHARMACY

Vaxart receives NIH grant for avian flu vaccine

BY Alaric DeArment

SAN FRANCISCO While H1N1 swine flu has hogged most of the publicity in the last few months, another potentially deadly form of the flu has not disappeared: the H5N1 avian flu.

San Francisco-based biotechnology company Vaxart announced that the National Institutes of Health had given it a $2.8 million grant to support the development of an orally administered vaccine for the highly pathogenic strain of the H5N1 flu that emerged in Asia in 2004 and has resulted in the deaths of approximately 60% of people infected.

“We thank the NIH for funding the further safety and efficacy tests, which, along with our previous successful animal studies, will pave the way towards clinical trials,” principal investigator Sean Tucker said in a statement.

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Giant Eagle to offer free generic antibiotics

BY Allison Cerra

NEW YORK Giant Eagle is offering a dose of economic relief to its customers by filling prescriptions for 10 widely used antibiotics for free, the company announced last week.

Common infections that these free antibiotics treat range from strep throat, ear infections and conjunctivitis to bladder infections, pneumonia, acne, urinary tract and skin infections. Some of the antibiotics are also used as a means to prevent infections caused by certain dental procedures.

“The Giant Eagle Pharmacy is committed to improving the health and wellness of our communities, especially during the back-to-school season when children and families begin to move indoors and become more susceptible to bacteria-related illness,” said VP pharmacy Randy Heiser. “This new free antibiotic program is expected to result in $4.6 million in annual cost savings for our customers, helping children and adults alike obtain these important antibiotics.”

Since November 2004, Giant Eagle has delivered approximately $218 million in lowered everyday prices on meat and chicken, grocery items and generic and over-the-counter medications, with plans to continue these price reductions efforts in the future, Giant Eagle said in a release. The company also provides savings through its popular promotional programs such as fuelperks!, weekly specials and double coupons.

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FDA to further review Takeda diabetes drug

BY Allison Cerra

DEERFIELD, Ill. A subsidiary of a Japan-based pharmaceutical company received a complete response letter from the Food and Drug Administration regarding a drug designed to control glucose levels in diabetes patients.

The FDA informed Takeda on June 26, 2009 that further review of the alogliptin monotherapy NDA would be conditional based upon additional data from a cardiovascular safety study that satisfies the statistical requirements of the December 2008 FDA Guidance titled, “Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.”

The complete response letter was specific to the FDC of alogliptin and ACTOS, and did not include any new questions or concerns about alogliptin or ACTOS.

“This complete response letter from the FDA is consistent with the June 26 complete response letter for alogliptin, a key component of the alogliptin and ACTOS fixed-dose combination product,” said Nancy Joseph-Ridge, M.D., general manager, pharmaceutical development division. “The FDA recently agreed to the study design for a cardiovascular outcomes trial for alogliptin, titled EXAMINE, and patient enrollment is planned to begin this month. We anticipate that the EXAMINE trial will provide the FDA with the information needed to continue the NDA reviews of both the alogliptin monotherapy and the alogliptin and ACTOS fixed-dose combination.”

ACTOS is a prescription medication used with diet and exercise to improve glucose control in adults with Type 2 diabetes.

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